Quality Assurance Manufacturing

Frankie Arce

** ******** *****

Jefferson, GA ***49

Cell 706-***-****

*******.****@*****.***

Purpose:

To acquire employment in which I can use my leadership skills, aseptic

techniques and sterile processing.

JOB EXPERIENCE:

Merial, Athens GA

06/2012-10/2012

Supervisor Small Volume Filling/Lyophilization

. Aseptic filling of vaccines in a clean room ISO 5/ class 100, 10,000

and 100,000 clean room following GMP`s, FDA and USDA guidelines.

. Operation of autoclaves and terminal sterilization of equipment.

. Prepare daily/weekly production schedule, batch documentation and

allocation of appropriate resources to the production teams.

. Ensure documentation is compliant with regulatory requirements.

. Oversee training and qualification of team members.

. Conduct annual employee performance reviews and assign individual

goals/objectives.

. Analyze key improvement opportunities and implement new ideas.

. Manage departmental expenses to ensure budget adherence.

. Initiate/facilitate root cause analysis and implement corrective and

preventative actions to address problems.

. Ensure equipment and facilities are properly maintained.

. Perform quarterly reviews and revisions to all process documentation.

. Address all safety related matters within department.

Dendreon Corporation, Morris Plains NJ

06/2010-03/2012

Cell Processing Operations

. Aseptic GMP manufacturing of clinical and commercial human blood

therapeutics in a clean room ISO 5 environment with biological safety

cabinets.

. Assist in validating protocols affecting the manufacturing equipment

or environment.

. Maintain SOP`s, batch records and other applicable documentation to

comply with regulatory requirements and GMP`s.

. Act as a subject matter expert, leading, mentoring and training other

associates in clean room behavior, aseptic process techniques, GMP

documentation, quality systems and safety.

. Perform batch record review for compliance.

. Assist QA in identifying and documenting process deviations, change

controls and corrective actions (CAPA).

Fisher Clinical Services, Allentown PA

12/2009-05/2010

Packaging Supervisor

. Coordinate packaging operations

. Training of packaging personnel

. Enforce CGMP`s and quality processes

. Review packaging documentation for accuracy

. Assist QA in identifying and documenting process deviations, change

controls and corrective actions (CAPA)

. Perform yearly personnel performance review

. Interview and hiring of packaging personnel

. Enforce safety protocols and procedures.

Greenstar North America, Northampton PA

09/2008-10/2009

Manager Production/Warehouse/Shipping/Quality

. Coordinate daily production and safety initiatives

. Coordinate quality inspections and initiatives

. Coordinate shipping and warehouse operations

. Enforce Safety Policies and OSHA regulations

. Develop Work Instructions

. Oversee operations of MRF, Warehouse and Shipping

. Manage production goals of Supervisors

. Manage MPT Tool for Shipping, Personnel, Downtime and Production

Wyeth Vaccines, Pearl River NY

01/2006-07/2008

Associate Supervisor

. Addition of Vaccine conjugates into processing tanks using strict

CGmp`s and FDA guidelines

. Clean in Place (CIP) of process tanks and ancillary equipment.

. Steam in Place (SIP) of process tanks, holding vessels and delivery

lines

. Sampling of batches and delivery of samples to quality assurance for

testing

. Work in clean room/sterile area (class 100,10,000 and 100,000)

. Batch Record Review for clarity mathematical errors and compliance

. Process monitoring

AAI Pharma Development Services, Charleston, SC

11/2003-01/2006

LEAD OPERATOR, (Contract, Commercial and Clinical Manufacturing)

. Train/coach operators in aseptic manufacturing processes, CGmp`s and

aseptic techniques.

. Coordinate multiple activities within department.

. Work in clean room/sterile area (class 100, 10,000 and 100,000).

. Coordinate required workflow.

. Facilitate the timely completion of job tasks.

. Daily scheduling of manufacturing personnel.

. Reviewing of Batch Records for proper documentation, calculations,

ect.

. Module and compounding room clearances and startup.

. Organize manufacturing areas, sterile manufacturing, prep area,

sterile filling, lyphilization and packaging.

PFIZER PHARMACEUTICALS INC., BROOKLYN, NY

08/1997-10/2003

Aseptic Department Manufacturing Supervisor

. Train/coach operators in production processes, CGmp`s and aseptic

techniques.

. Work in clean room/sterile area (class 100,10,000 and 100,000)

. Coordinate multiple activities within department.

. Coordinate with other department/departmental areas(sterile filling,

sterile compounding, NS liquids compounding, prep area and packaging)

required workflow.

. Facilitates the timely completion of job tasks.

. Ensure inventory levels of operating supplies and chemicals are

maintained.

. Work with area Technical Specialist to implement process improvements.

. Verify accurate and completed documentation of procedures and

practices.

. Tracking of labor hours and provide tallies to area clerk.

04/2005-Present United States Air Force Reserve (Air Transportation), Air

National Guard (Fuels POL)

Other positions held/ training

. Safety representative- in charge of safety issues and auditing in both

the

manufacturing and shipping areas. Responsible of safety audits

with

safety team.

. Train the trainer

. Hazcom trained.

. Transporter, forklift certified.

. Communications training.

. CGMP's training.

EDUCATION:

. 2006-2008, Muhlenberg College

. 1990-1991, 1995-1996 InterAmerican University of Puerto Rico

. 1986-1990 Eastern District High School

SKILLS

. COMPUTER: Microsoft Business Package

. LANGUAGE: Fluent in English and Spanish.

REFERENCES FURNISHED UPON REQUEST

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